Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent

Not Applicable

Completed

Conditions: Atherosclerosis
Coronary Artery Disease

Interventions: Device: TAXUS Liberté Coronary Stent System
Device: PROMUS Element Coronary Stent System

Registration Number: NCT01285999

Lead Sponsor: Boston Scientific Corporation

Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System for the treatment of subjects in China with a single de novo atherosclerotic coronary artery lesion.

Detailed Description: A prospective, multi-center, randomized-controlled, single-blind, superiority trial at up to 15 sites in China to enroll 500 subjects (3:1 randomization PROMUS Element to TAXUS Liberté) with a single de novo lesion \<38mm in length (by visual estimate) in a native coronary artery ≥2.50mm to ≤4.00 mm in diameter (by visual estimate).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 500

Inclusion Criteria

Subject must be age 18 - 75 years
Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial- specific tests or procedures are performed
Subject is eligible for percutaneous coronary intervention (PCI)
Subject has symptomatic coronary artery disease or documented silent ischemia
Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
Subject has a left ventricular ejection fraction (LVEF) ≥30% as measured within 60 days prior to enrollment
Subject is willing to comply with all protocol-required follow-up evaluations

Angiographic Inclusion Criteria:

Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤ 4.00 mm.
Target lesion length must measure <38 mm (by visual estimate)
Target lesion must have visually estimated stenosis ≥50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1.
Target lesion must be successfully pre-dilated.

Exclusion Criteria

Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI
Subject with unstable angina or recent MI (within 1 week) must have creatine kinase (CK)/ creatine kinase-myoglobin band(CK-MB) or troponin documented prior to the procedure and are excluded if any of the following criteria are met at the time of the index procedure:
- of CK MB >2× upper limit of normal (ULN), the subject is excluded regardless of the CK Total.
- If CK Total >2× ULN, either CK-MB or troponin must be drawn and the subject is excluded if either CK-MB or troponin is abnormal.
- If neither CK Total or CK MB is drawn but troponin is, the subject is excluded if troponin >1× ULN and the subject has at least one of the following:
  - Subject has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., >1 mm stent thrombosis (ST) segment elevation or depression in consecutive leads or new left bundle branch block (LBBB)
  - Development of pathological Q waves in the ECG or;
  - Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality Note: Subjects who do not have recent MI or unstable angina must still have CK/CK-MB or troponin drawn prior to the index procedure. However, the results for these subjects do not need to be available prior to the index procedure and there are no exclusion criteria based on these laboratory studies.
Subject has received an organ transplant or is on a waiting list for an organ transplant
Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
Subject is receiving oral or intravenous immunosuppressive therapy (Note: use of inhaled steroids does not exclude subjects) or has known life- limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; Note: this does not include diabetes mellitus)
Subject is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, coumadin) for indications other than acute coronary syndrome
Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
Subject has a white blood cell (WBC) count <3,000 cells/mm3
Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
Subject is on dialysis or has serum creatinine level >2.0 mg/dL
Subject has active peptic ulcer disease, an active gastrointestinal (GI) bleed, other bleeding diathesis or coagulopathy or will refuse transfusions
Subject has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
Target vessel (including side branches) has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure
Target vessel has been treated within 10 mm proximal or distal to the target lesion (by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to the index procedure
Non-target vessel has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to the index procedure
Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement
Planned PCI or CABG after the index procedure
Subject previously treated at any time with coronary intravascular brachytherapy
Subject has known allergy to the study stent system or protocol-required concomitant medications (e.g., everolimus, paclitaxel or structurally related compounds; fluoropolymers; thienopyridines or aspirin; contrast; acrylic; stainless steel; platinum; chromium; nickel; iron; tungsten) that cannot be adequately premedicated
Subject has any other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months
Subject has current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
Subject has a planned procedure that may cause non-compliance with the protocol or confound data interpretation
Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint or intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
Subject with known intention to procreate within 12 month after the index procedure (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 month after the index procedure.)
Subject is a woman who is pregnant or nursing (A pregnancy test must be performed within 7 days prior to the index procedure in women of child- bearing potential.)
Subject has more than 1 lesion that requires treatment during the index procedure

Angiographic Exclusion Criteria:

Target lesion meets any of the following criteria:
- Left main location
- Located within 5 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery or Right Coronary Artery (RCA) by visual estimate
- Located within a saphenous vein graft or an arterial graft
- Will be accessed via a saphenous vein graft or an arterial graft
- Involves a side branch ≥2.0 mm in diameter by visual estimate
- Involves a side branch <2.0 mm in diameter by visual estimate which requires treatment
- TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
- Excessive tortuosity proximal to or within the lesion
- Excessive angulation proximal to or within the lesion
- Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
- Restenotic from previous intervention
- Thrombus, or possible thrombus, present in the target vessel
- Target lesion cannot be covered by a single study stent (unplanned bailout stenting is allowed)
Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
Subject has protected left main coronary artery disease (>50% diameter stenosis in the left main coronary artery (LMCA) with bypass graft[s] to the left coronary artery) and a target lesion in the LAD or LCX
Subject has an additional clinically significant lesion(s) for which an intervention within 12 months after the index procedure may be required

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAXUS Liberté	TAXUS Liberté Coronary Stent System	TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
PROMUS Element	PROMUS Element Coronary Stent System	PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)

Primary Outcome Measures

Name	Time	Method
9 Month In-stent Late Loss	9 Months	The primary endpoint is in-stent late loss measured by quantitative coronary angiography (QCA) at 9 months post-index procedure.

Secondary Outcome Measures

Name	Time	Method
Target Vessel Failure (TVF) Rate	In hospital and at 2 years
Target Lesion Revascularization (TLR) Rate	In hospital and at 2 years
Target Vessel Revascularization (TVR) Rate	In hospital and at 2 years
Target Lesion Failure (TLF) Rate	In hospital and at 2 years
Major Adverse Cardiac Event (MACE) Rate	In hospital and at 2 years
Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate	In hospital and at 2 years
Cardiac Death Rate	In hospital and at 2 years
Non-cardiac Death Rate	In hospital and at 2 years
All Death Rate	In hospital and at 2 years
Cardiac Death or MI Rate	In hospital and at 2 years
Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions)	In hospital and at 2 years
Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD)	9 months
Periprocedural Endpoints: Technical Success Rate, Clinical Procedural Success Rate	In hospital
Angiographic Endpoints: In-stent and In-segment Binary Restenosis Rate, Stent Fracture Rate	9 month
Minimal Lumen Diameter (QCA), Acute Gain (QCA)	In hospital

Trial Locations

Locations (15): TEDA International Cardiovascular Hospital
🇨🇳
Tianjin, China
Xijing Hospital, Fourth Military Medical University
🇨🇳
Xi'an, China
Cardiovascular Institute and Fu Wai Hospital
🇨🇳
Beijing, China
Peking Union Medical College Hospital
🇨🇳
Beijing, China
Peking University First Hospital
🇨🇳
Beijing, China
General Hospital of SY Military Institute
🇨🇳
Shenyang, China
The Chinese People's Liberation Army General Hospital
🇨🇳
Beijing, China
Huaxi Hospital of Sichuan University
🇨🇳
Chengdu, China
Daqing General Oil Field Hospital
🇨🇳
Daqing, China
Guangdong Cardiovascular Institute of Guangdong Provincial Hospital
🇨🇳
Guangzhou, China
Guangdong Nanfang Hospital
🇨🇳
Guangzhou, China
The 2nd Affiliated Hospital of Harbin Medical University
🇨🇳
Harbin, China
Nanjing First Hospital
🇨🇳
Nanjing, China
Shanghai 6th People's Hospital, Jiaotong University
🇨🇳
Shanghai, China
Shanghai Chest Hospital of Jiaotong University
🇨🇳
Shanghai, China